Song Pan, Liang Faya, Ye Yuchu, Huang Yongsheng, Wu Taowei, Huang Xiaoming, Han Ping
Department of Otolaryngology Head and Neck Surgery，Sun Yat-sen Memorial Hospital，Sun Yat-sen University，Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation，Guangzhou，510289，China.
Cellular & Molecular Diagnostics Center，Sun Yat-sen Memorial Hospital，Sun Yat-sen University.
Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2023 Oct;37(10):778-785. doi: 10.13201/j.issn.2096-7993.2023.10.003.
The aim of this retrospective study is to evaluate the safety and efficacy of tislelizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma. Six patients with recurrent/metastatic head and neck squamous cell carcinoma who received tislelizumab monotherapy in our hospital from 2018 to 2020 were retrospectively analyzed. The information of sex, age, TNM stage, efficacy, and adverse reactions were collected. All patients were recruited from the RATIONALE 102 study. The primary end point was the objective response rate, and other end points included progression-free survival and overall survival. We performed tumor immune-related gene sequencing and transcriptome sequencing analysis on the tumor tissues of the patient, and used bioinformatics methods to enrich immune cells and analyze signaling pathways. All analyses were performed using R 4.1. 0 software, SPSS Statistics 24.0 software and GraphPad Prism 8. As of May 31, 2020, the median follow-up time was 26.35 months. The objective response rate with tislelizumab was 50.0%, the median progression-free survival was 6.44 months, and the estimated median survival was 20.07 months. The incidence of grade 3 or higher adverse reactions was 66.7%, including hyponatremia, hypokalemia, hypercalcemia, etc. The expression of macrophage, Treg and neutrophil-related genes are higher in immune-sensitive patients, and the signaling pathways of the intestinal immune network for IgA production, graft versus host disease and autoimmune thyroid disease are significantly activated. Tislelizumab was found to be controllable and tolerable in patients with recurrent/metastatic head and neck squamous cell carcinoma. The response to tislelizumab is related to immune cell infiltration and activation of immune-related signaling pathways.
本回顾性研究旨在评估替雷利珠单抗治疗复发/转移性头颈部鳞状细胞癌患者的安全性和疗效。回顾性分析了2018年至2020年在我院接受替雷利珠单抗单药治疗的6例复发/转移性头颈部鳞状细胞癌患者。收集了患者的性别、年龄、TNM分期、疗效及不良反应等信息。所有患者均来自RATIONALE 102研究。主要终点为客观缓解率，其他终点包括无进展生存期和总生存期。我们对患者的肿瘤组织进行了肿瘤免疫相关基因测序和转录组测序分析，并采用生物信息学方法富集免疫细胞和分析信号通路。所有分析均使用R 4.1.0软件、SPSS Statistics 24.0软件和GraphPad Prism 8进行。截至2020年5月31日，中位随访时间为26.35个月。替雷利珠单抗的客观缓解率为50.0%，中位无进展生存期为6.44个月，估计中位生存期为20.07个月。3级及以上不良反应发生率为66.7%，包括低钠血症、低钾血症、高钙血症等。免疫敏感患者中巨噬细胞、调节性T细胞和中性粒细胞相关基因的表达较高，IgA产生的肠道免疫网络、移植物抗宿主病和自身免疫性甲状腺疾病的信号通路明显激活。结果发现，替雷利珠单抗在复发/转移性头颈部鳞状细胞癌患者中是可控且可耐受的。对替雷利珠单抗的反应与免疫细胞浸润和免疫相关信号通路的激活有关。
